MalfunctionMMQ
ALLEGRO TOPOLYZER VARIO
Received Nov 30, 2012 · Event occurred Nov 1, 2012
Report 3003288808-2012-00494 · MDR key 2854755
Device
Generic name
Corneal Topography System
Manufacturer
Wavelight GmbhModel number
8065990710Catalog number
8065990710
Lot number
NA
Product problems
- Incorrect Measurement
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A SURGEON REPORTED THAT THE MEASUREMENTS OF ONE PT WERE ASSOCIATED WITH THE NAME OF ANOTHER PT. THE MEASUREMENTS WERE NOT USED TO DEVELOP ANY TREATMENTS, AND THERE WAS NO HARM TO ANY PT.
Additional Manufacturer Narrative
INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDING WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).